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Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress

Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress: A Pilot Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07714083
Enrollment
52
Registered
2026-07-20
Start date
2026-10-01
Completion date
2030-07-01
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder

Keywords

Cognitive Processing Therapy (CPT), Lived experience stress, Lived Experience Adapted Protocol (LEAP), Veterans

Brief summary

Populations facing health disparities include groups with significantly higher rates of posttraumatic stress disorder than the general population who frequently experience lived experience stress, which may complicate posttraumatic stress disorder symptom presentations. However, there are currently no posttraumatic stress disorder treatments designed to meet the unique needs of these individuals. The proposed study will pilot an adaptation of Cognitive Processing Therapy (a gold-standard treatment for posttraumatic stress disorder) that has been modified to incorporate the impact of lived experience stress as an additional treatment target. This project has the potential to advance our understanding of how to enhance Cognitive Processing Therapy in order to optimize posttraumatic stress disorder treatment response and mitigate health disparities.

Detailed description

This study will occur in two phases. Phase 1 will involve refining Cognitive Processing Therapy Lived Experience Adapted Protocol (CPT-LEAP) and includes beta testing of CPT-LEAP (n=6). Phase 2 will involve a pilot RCT in which participants (n=52) will be randomized (1:1) to standard CPT or CPT-LEAP. The investigators anticipate 26 participants will be enrolled in each treatment arm.

Interventions

BEHAVIORALStandard CPT

CPT focuses on teaching skills to identify and challenge PTSD-maintaining maladaptive beliefs related to the trauma itself, the world, and oneself. Worksheets and assignments are given between each session.

BEHAVIORALCPT-LEAP

CPT-LEAP frames each session in relation to beliefs about both traumatic and lived experience stressors and their interactions and impacts, including not only beliefs about oneself, others, and the world, but also one's identity, and use of relevant examples throughout the protocol.

Sponsors

Boston University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Current diagnosis of PTSD * Self-identification as a sexual or gender minority (SGM) individual * Endorsement of SGM stress experiences with moderate distress * For patients who take psychiatric medication, stable dose one month prior to enrollment * Reside in Massachusetts.

Exclusion criteria

* Current active suicidal or homicidal ideation with intent or plan * Unstable bipolar disorder/current mania * Unstable psychotic disorder/current psychosis * Current severe substance use that warrants immediate medical attention * Cognitive impairment or organic disorder (e.g., advanced dementia, severe traumatic brain injury) that impairs ability to complete CPT procedures * Past completion of CPT or current trauma-focused treatment * Unwillingness to consent to audio or video recording of assessment and treatment sessions

Design outcomes

Primary

MeasureTime frameDescription
Post traumatic stress disorder symptoms (PTSD)immediately after treatment, 3 monthsClinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5). The CAPS-5 includes 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.

Countries

United States

Contacts

CONTACTCara Herbitter, PhD, MPH
Cara.Herbitter@va.gov857-364-6528
PRINCIPAL_INVESTIGATORCara Herbitter, PhD, MPH

Psychiatry CABUSM and National Center for PTSD, VA Boston Healthcare System

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026